# K213413: Hemostatic Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Newvalue Medical Products Co., Ltd.
- Decided: Sep 1, 2023 after 682 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K002550 (2000). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090026: Chitogauze, Models 130, 131, 263, 264, 265, 266, Hem Con Medical Technologies, Inc. (2009) Summary page 5.

## Indications for use
Hemostatic Dressing is intended for the external, temporary control of severely bleeding wounds. Hemostatic Dressing is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.

Source page: https://510kreport.com/device/K213413
Methodology: https://510kreport.com/methodology